EBV IgG Control EBG-5020

GUDID B110EBG50200

Bion Enterprises, Ltd.

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110EBG50200
NIH Device Record Key94ef2e7d-98de-428f-9820-861b4ad9ddb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBV IgG Control
Version Model NumberEBG-5020
Catalog NumberEBG-5020
Company DUNS024824641
Company NameBion Enterprises, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110EBG50200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJNAntibody Igm, If, Epstein-Barr Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-04
Device Publish Date2016-09-12

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